Purpose

To investigate the repeatability of waveform signal parameters, measured with the Ocular Response Analyzer (ORA), in children.

Methods

Two sets of ORA measurements, with a 10-min break between them, were performed on children, aged six to <11 years old, either wearing single-vision spectacles (SVS) or orthokeratology (ortho-k) lenses. Intraclass correlation coefficients (ICCs) were used to assess agreements between two sets of measurements (37 waveform signal parameters). Bland-Altman (BA) plots were used to further analyse waveform signal parameters which had ICC 95 % confidence interval (95 % CI) between 0.50 to >0.90 (regarded as moderate to excellent agreement).

Results

A total of 30 participants [15 SVS, 15 ortho-k (3.6 ± 2.4 months)] completed the study. Since no significant between-group differences were detected in demographic data (p > 0.28) and all waveform signal parameters (p > 0.05), data from the two groups of participants were pooled for the analysis of repeatability. Six parameters, h2, h21, p1area, p1area1, p2area, and p2area1, achieved ICCs (95 % CI) of 0.82−0.85 (0.61−0.93). The mean (SD) of these six parameters were 372 (91), 248 (61), 4077 (854), 1762 (399), 2359 (670), and 1020 (300), respectively. Bland-Altman plots and 95 % limits of agreement (95 % LoA) showed considerable agreement for all six parameters, the mean difference (95 % LoA) were -3 (-101 to 94), -2 (-67.56–62.70), 111 (-723 to 946), 102 (-334 to 539), 25 (-718 to 768), and -3 (-350 to 343), respectively.

Conclusions

Six waveform signal parameters (h2, h21, p1area, p1area1, p2area, and p2area1), which represent or are related to the areas under the waveform at the peaks in the signal, had moderate to excellent agreement in children. Results of the current study provides fundamental information for further studies on the potential clinical application of these waveform signal parameters in children.

中文翻译：

---

儿童眼反应分析仪得出的角膜生物力学波形信号参数的可重复性

目的

研究使用眼反应分析仪 (ORA) 测量的儿童波形信号参数的可重复性。

方法

对 6 至 <11 岁的儿童进行了两组 ORA 测量，它们之间有 10 分钟的休息时间，佩戴单光眼镜 (SVS) 或角膜矫正术 (ortho-k) 镜片。组内相关系数 (ICC) 用于评估两组测量值（37 个波形信号参数）之间的一致性。Bland-Altman (BA) 图用于进一步分析波形信号参数，其 ICC 95% 置信区间 (95% CI) 在 0.50 到 >0.90 之间（被视为中等至极好的一致性）。

结果

共有 30 名参与者 [15 SVS, 15 ortho-k (3.6 ± 2.4 个月)] 完成了这项研究。由于在人口统计学数据 (p > 0.28) 和所有波形信号参数 (p > 0.05) 中没有检测到显着的组间差异，因此将两组参与者的数据合并用于可重复性分析。六个参数 h2、h21、p1area、p1area1、p2area 和 p2area1 的 ICC (95% CI) 为 0.82-0.85 (0.61-0.93)。这六个参数的平均值 (SD) 分别为 372 (91)、248 (61)、4077 (854)、1762 (399)、2359 (670) 和 1020 (300)。Bland-Altman 图和 95 % 的一致性限制 (95 % LoA) 显示所有六个参数都具有相当大的一致性，平均差异 (95 % LoA) 为 -3（-101 至 94）、-2（-67.56-62.70），分别为 111（-723 至 946）、102（-334 至 539）、25（-718 至 768）和 -3（-350 至 343）。

结论

六个波形信号参数（h2、h21、p1area、p1area1、p2area 和 p2area1）代表或与信号峰值处波形下的面积相关，在儿童中具有中等至极好的一致性。当前研究的结果为进一步研究这些波形信号参数在儿童中的潜在临床应用提供了基础信息。